Efficacy and Safety of Enteric-Coated Mycophenolate Sodium (EC-MPS) in de Novo Kidney Transplant Recipients：A Large, Multiple-Center Prospective Study
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 270
- 主要终点
- Incidence of acute rejection
研究概览
简要总结
At present, imitation EC-MPS have just come on the market, no clinical studies have confirmed the efficacy and safety of using imitation EC-MPS for immunosuppressive therapy after kidney transplantation. Therefore, there is an urgent need to conduct a multicenter study in China to provide further guidance for the use of imitated mycophenol sodium enteric-coated tablets in kidney transplant patients. Therefore, this study will analyze whether the anti-rejection effect of generic EC-MPS in the treatment of renal transplantation in Chinese population is equivalent to that of the original EC-MPS, in order to provide reference for clinical rational drug use.
详细描述
Under the premise that tacrolimus is used as basic immunosuppressant, to explore the efficacy and safety of imitation mecophenol sodium enteric-coated tablets (EC-MPS) compared with the original preparation agent (Miv) in Chinese kidney transplant patients.
This study was divided into experimental group and control group. The experimental group was imitation mycophenol sodium enteric-coated tablets, and the control group was original mycophenol sodium enteric-coated tablets. Both groups were treated with the triple immunosuppressive regimen of "Mycopherol sodium enteric-coated tablets (EC-MPS) + tacrolimus (TAC) + glucocorticoid" immediately after transplantation for at least 12 months. Tacrolimus, glucocorticoid and antibody induction can be treated according to the clinical routine diagnosis and treatment path, and no specific restrictions were made in this study
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female, aged 18-65;
- •Patients with end-stage renal disease who received live/cadaveric kidney transplantation for the first time;
- •After kidney transplantation, patients were subjected to a routine triple immunosuppressive regimen, namely "mecophenol sodium enteric-coated tablets (EC-MPS) + tacrolimus (TAC) + glucocorticoid" regimen;
- •The patients signed informed consent, were able to follow up regularly and fully collect information related to this study.
排除标准
- •Multi-organ recipients, such as those with heart, lung, liver and other organ transplants;
- •ABO incompatible kidney transplant recipients;
- •HLA antibodies or past/current population reactive antibody level (PRA) > 25% were preexisting in the recipient before renal transplantation;
- •Allergic to EC-MPS or preparation components (hypersensitivity);
- •Women with fertility potential who are pregnant, lactating or planning to become pregnant;
- •Severe/uncontrolled concomitant infections or other serious medical problems;
- •Active bacterial, viral or fungal infections;
- •Neutropenia (ANC<1.3×103/µL)
- •Patients judged by the investigator to be unsuitable for inclusion in this study for other reasons.
研究组 & 干预措施
Original EC-MPS（myfortic）
干预措施: Enteric-Coated Mycophenolate Sodium (EC-MPS) (Drug)
Imitation EC-MPS(Ruiyirong)
干预措施: Enteric-Coated Mycophenolate Sodium (EC-MPS) (Drug)
结局指标
主要结局
Incidence of acute rejection
时间窗: 12 months after renal transplantation
次要结局
- Incidence of gastrointestinal reactions(12 months after renal transplantation)
研究者
Zhishui Chen
Professor
Tongji Hospital